Commonwealth Numbered Acts Commonwealth Numbered Acts
1 Subsection 3(1) (definition of British Pharmacopoeia )
Repeal the definition, substitute:
"British Pharmacopoeia" means the edition of the publication of that name, including any additions or amendments, that was in effect for the purposes of this Act immediately before the commencement of Schedule 4 to the Therapeutic Goods Amendment (Medical Devices and Other Measures) Act 2009 and, if additions or amendments of that publication are made after that commencement, or new editions of that publication are published after that commencement, includes those additions or amendments, or those new editions, from the effective date published by the British Pharmacopoeia Commission or any replacement body.
2 Subsection 3(1) (definition of British Pharmacopoeia (Veterinary) )
Repeal the definition.
3 Subsection 3(1)
Insert:
"default standard" means any of the following:
(a) a standard referred to in paragraph (b) of the definition of standard in this subsection;
(b) a standard referred to in paragraph (c) of that definition;
(c) a standard referred to in paragraph (d) of that definition.
4 Subsection 3(1)
Insert:
"European Pharmacopoeia" means the English edition of the publication of that name, including any additions or amendments, that was in effect immediately before the commencement of this definition and, if additions or amendments of that publication are made after that commencement, or new editions of that publication are published after that commencement, includes those additions or amendments, or those new editions, from the effective date published by the Council of Europe or any replacement body.
5 Subsection 3(1) (paragraph (a) of the definition of medicine )
Omit "or animal".
6 Subsection 3(1) (definition of standard )
Repeal the definition, substitute:
"standard" , in relation to therapeutic goods, means any of the following:
(a) a standard that is constituted by the matters specified in an order under section 10 that is applicable to the goods;
(b) if the goods are the subject of one or more monographs (other than a monograph exempt under subsection 3C(1)) in the British Pharmacopoeia--a standard that is constituted by the statements (other than statements exempt under subsection 3C(2)) in those monographs, as interpreted in accordance with the General Notices section of the British Pharmacopoeia;
(c) if the goods are the subject of one or more monographs (other than a monograph exempt under subsection 3C(1)) in the European Pharmacopoeia--a standard that is constituted by the statements (other than statements exempt under subsection 3C(2)) in those monographs, as interpreted in accordance with the General Notices section of the European Pharmacopoeia;
(d) if the goods are the subject of one or more monographs (other than a monograph exempt under subsection 3C(1)) in the United States Pharmacopeia‑National Formulary--a standard that is constituted by the statements (other than statements exempt under subsection 3C(2)) in those monographs, as interpreted in accordance with the General Notices section of the United States Pharmacopeia‑National Formulary.
Note: See also section 13.
7 Subsection 3(1) (paragraph (c) of the definition of supply )
Omit "or animals".
8 Subsection 3(1) (paragraph (d) of the definition of supply )
Omit "or animal".
9 Subsection 3(1) (definition of therapeutic use )
Omit "or animals" (wherever occurring).
10 Subsection 3(1)
Insert:
"United States Pharmacopeia-National Formulary" means the English edition of the publication of that name, including any additions or amendments, that was in effect immediately before the commencement of this definition and, if additions or amendments of that publication are made after that commencement, or new editions of that publication are published after that commencement, includes those additions or amendments, or those new editions, from the effective date published by the United States Pharmacopeial Convention or any replacement body.
11 Subsection 3(2)
Repeal the subsection, substitute:
(2) For the purposes of this Act, therapeutic goods are taken to be for use in humans if they are not solely for use in animals.
12 After section 3B
Insert:
3C Exempting monographs in pharmacopoeias
Exempting entire monographs
(1) The Minister may, by legislative instrument, determine that specified monographs in the British Pharmacopoeia, the European Pharmacopoeia or the United States Pharmacopeia‑National Formulary are exempt for the purposes of paragraph (b), (c) or (d) of the definition of standard in subsection 3(1).
Note: For specification by class, see subsection 13(3) of the Legislative Instruments Act 2003 .
Exempting parts of monographs
(2) The Minister may, by legislative instrument, determine that specified statements in specified monographs in the British Pharmacopoeia, the European Pharmacopoeia or the United States Pharmacopeia‑National Formulary are exempt for the purposes of paragraph (b), (c) or (d) of the definition of standard in subsection 3(1).
13 Subsection 10(1)
Omit "or the British Pharmacopoeia (Veterinary)", substitute ", the European Pharmacopoeia or the United States Pharmacopeia‑National Formulary".
14 Subparagraph 10(2)(a)(iv)
Omit "or the British Pharmacopoeia (Veterinary)", substitute ", the European Pharmacopoeia or the United States Pharmacopeia‑National Formulary".
15 Section 13
Repeal the section, substitute:
13 Special provisions relating to standards
(1) For the purposes of this Act, if a statement (the main statement ) in a monograph in the British Pharmacopoeia, the European Pharmacopoeia or the United States Pharmacopeia‑National Formulary refers to a statement in a monograph in another publication, the main statement is taken to include the other statement.
(2) If:
(a) a standard under section 10 (the Ministerial standard ) applies to therapeutic goods; and
(b) requirements applicable to the goods are specified in a default standard; and
(c) those requirements are inconsistent with the requirements specified in the Ministerial standard;
the requirements referred to in paragraph (b) are, so far as they are inconsistent, to be disregarded for the purposes of this Act.
(3) If:
(a) a default standard applies to a class of therapeutic goods; and
(b) another default standard applies to only some of the therapeutic goods within that class; and
(c) those standards are inconsistent;
the standard referred to in paragraph (a) does not apply in relation to the goods referred to in paragraph (b).
(4) If:
(a) therapeutic goods consist, or are represented to consist, of a mixture of ingredients or of a combination of component parts; and
(b) a default standard is applicable to one or more of the ingredients or one or more of the component parts; and
(c) a default standard is applicable to the mixture or combination;
the standard referred to in paragraph (b) does not apply in relation to the goods.
(5) If:
(a) therapeutic goods consist, or are represented to consist, of a mixture of ingredients or of a combination of component parts; and
(b) there is no standard applicable to the mixture or combination but a standard is applicable to one or more of the ingredients or one or more of the component parts;
the Minister may, by order published in the Gazette , determine that the standard does not apply to the goods. The order has effect accordingly.
(6) An order under subsection (5) is not a legislative instrument.
(7) For the purposes of this Act, in working out at a particular time if therapeutic goods conform with a default standard applicable to the goods, if:
(a) after applying subsections (2) to (5), 2 or more default standards are applicable to the goods at that time; and
(b) at that time, the goods conform with at least one of those standards but do not conform with at least one of those standards;
then the default standards that the goods do not conform with are taken not to apply to the goods at that time.
16 Subsection 30F(2)
Omit "or animal".
17 Paragraph 41CC(1)(b)
Omit "United States Pharmacopoeia", substitute "United States Pharmacopeia‑National Formulary".
18 Subsection 42V(3)
Omit "or animal".
19 Section 56
Omit "and of the British Pharmacopoeia (Veterinary)", substitute ", the European Pharmacopoeia and the United States Pharmacopeia‑National Formulary".
20 Application and transitional
(1) If:
(a) immediately before the commencement of this item, therapeutic goods were registered goods or listed goods; and
(b) at a particular time within the period of 12 months beginning on the day on which this item commences:
(i) a standard referred to in paragraph (c) or (d) of the definition of standard in subsection 3(1) of the Therapeutic Goods Act 1989 (as amended by this Act) would, apart from this subitem, apply to the goods; and
(ii) the goods do not conform with that standard;
then that standard is taken not to apply to the goods at that time.
(2) To avoid doubt, paragraph (a) of the definition of standard in subsection 3(1) of the Therapeutic Goods Act 1989 (as amended by this Act) applies in relation to orders made under section 10 of the Therapeutic Goods Act 1989 before, on or after the commencement of this item.
(3) An order in force under paragraph 13(7)(c) of the Therapeutic Goods Act 1989 immediately before the commencement of this item has effect, on and after that commencement, as if it were an order in force under subsection 13(5) of that Act.